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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name spirometer, diagnostic
510(k) Number K951227
Device Name DX1
Applicant
CREATIVE BIOMEDICS, INC.
934-B CALLE NEGOCIO
SAN CLEMENTE,  CA  92673
Applicant Contact DANIEL BROWN
Correspondent
CREATIVE BIOMEDICS, INC.
934-B CALLE NEGOCIO
SAN CLEMENTE,  CA  92673
Correspondent Contact DANIEL BROWN
Regulation Number868.1840
Classification Product Code
BZG  
Date Received03/20/1995
Decision Date 08/11/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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